A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers
- Conditions
- Advanced/Metastatic Non-Small Cell Lung CancerCarcinoma, Non-Small Cell LungNon-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT07227298
- Lead Sponsor
- Pfizer
- Brief Summary
This study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in people who have advanced solid tumors. An advanced solid tumor is a type of cancer that has spread beyond its original location and cannot be removed by surgery or cured with standard treatments.
To join in the study, participants must:
* Be 18 years or older
* Participants with advanced non-small cell lung cancer (NSCLC), a type of lung cancer that has spread
The study will look at:
* Whether PF-08634404 is safe to use with other cancer medicines.
* What side effects may happen. A side effect is anything the medicine does to your body that is not part of treating your disease.
* Whether the combination of PF-08634404 and other cancer medicines can help treat solid tumors.
The study has different parts, each testing PF-08634404 with a different cancer medicine:
* Part A will test PF-08634404 with a medicine called sigvotatug vedotin.
* Part B of the study will look at how well the new medicine PF-08634404 works when used together with another medicine.
Participants will receive the study medicines through an intravenous (IV) infusion (injected into the vein) at the study clinic. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 162
- Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy
- PD-L1 status available
- Part B only: PD-L1 ≥ TPS 1%
- Measurable disease based on RECIST v1.1 per investigator.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ function
- Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET
- History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy
- Known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
- Leptomeningeal disease
- Active autoimmune diseases requiring systemic treatment within the past 2 years
- Previous systemic anti-tumor therapy for locally advanced, unresectable, or metastatic NSCLC
- Previous treatment with immunotherapy (exception is (neo)adjuvant anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy to the lung within 6 months of first dose of study intervention
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description PF-08634404 + Sigvotatug Vedotin (Part A) PF-08634404 Participants will receive PF-08634404 in combination with Sigvotatug Vedotin. PF-08634404 + Sigvotatug Vedotin (Part A) Sigvotatug Vedotin Participants will receive PF-08634404 in combination with Sigvotatug Vedotin. PF-08634404 + Combination Agent 1 (Part B) PF-08634404 Participants will receive PF-08634404 in combination with other anticancer agent as per protocol. PF-08634404 + Combination Agent 1 (Part B) Combination Agent 1 Participants will receive PF-08634404 in combination with other anticancer agent as per protocol.
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Through 90 days after the last study intervention; Up to approximately 5 years AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Phase I: Number of participants with dose limiting toxicity (DLT) Through 90 days after the last study intervention; Up to approximately 5 years Dose limiting toxicity based on dose limiting toxicity evaluable participants. The number of participants who experienced DLTs during the DLT observation period.
Phase 2: Confirmed Objective Response Rate (ORR) per RECIST v1.1 by investigator Up to approximately 5 Years ORR is defined as the proportion of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or confirmed Partial Response (PR) per RECIST v1.1.
- Secondary Outcome Measures
Name Time Method Disease Control Rate (DCR) per RECIST v1.1 by investigator Up to approximately 5 years DCR by investigator assessment is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) by investigator assessment per RECIST version 1.1.
Phase I: Confirmed ORR per RECIST v1.1 by investigator Up to approximately 5 Years ORR is defined as the proportion of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or confirmed Partial Response (PR) per RECIST v1.1.
Duration of Response (DOR) per RECIST v1.1 by investigator Up to approximately 5 years DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
Progression Free Survival (PFS) per RECIST v1.1 by investigator Up to approximately 5 years Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first.
Number of Participants With Clinical Laboratory Abnormalities Through 90 days after the last study intervention; Up to approximately 5 years Pharmacokinetics (PK): Serum concentration of PF-08634404 with anticancer agents Up to 37 days after the last dose of treatment To characterize the pharmacokinetics (PK) of PF-08634404 with anticancer agents.
Incidence of Anti-Drug Antibody (ADA) against PF-08634404 with anticancer agents Up to 37 days after the last dose of treatment To characterize the immunogenicity of PF-08634404 with anticancer agents.